Industrial designers are an increasingly integral part of medical and healthcare spaces, entering the work stream early in the assessment of user needs. In addition to understanding the needs and requirements of users, understanding the regulatory landscape is imperative for the approval and acceptance of medical devices. Design controls is a process required by the Food and Drug Administration (FDA) and is instrumental in verification and validation of medical devices. This process can be implemented to create a traceable map that links user needs to the tangible design.

Traceability integration provides industrial design students a formal set of checks and balances. This facilitates well-considered and deliberate design decisions throughout the project, culminating in a deliverable that meets project requirements. Incorporating principles of design controls in an industrial design studio setting will reinforce student design process understanding, promote communication through traceable linkages and provide insight into the nuances of medical device design.